NEW YORK, NY—PharmaCyte Biotech (OTCQB: PMCB) is a California-based biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, and while it continues to focus on submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for its treatment for locally advanced, inoperable pancreatic cancer, it has also seized an opportunity to offer testing kits for the coronavirus disease (COVID-19). According to the company’s investor relations, this opportunity would create a revenue stream for its pancreatic cancer program.
The virus—known as “Severe Acute Respiratory Syndrome Coronavirus 2” or “SARS-CoV-2,” causes the disease COVID-19, which has become a global pandemic that will require testing for the foreseeable future, including after a cure can be developed and approved for the disease. To that end, through relationships that PharmaCyte has developed in Hong Kong, it has partnered with Hai Kang Life Corporation (Hai Kang) to deliver a testing solution that could offer a much more accurate test than is currently being used globally.
The first step is to apply to the U.S. FDA for Emergency Use Authorization and prove that the test manufactured by Hai Kang works for the purposes of detecting the SARS-CoV-2 virus. It’s a process that can take as little as a few weeks. PharmaCyte’s investor relations said of its partnership with Hai Kang, “We will be able to help with the shortage of accurate diagnostic kits. If we obtain approval, it should provide an immediate and material stream of revenue to us to help fund our other endeavors, while at the same time, helping a world in dire need for the product we are trying to get approved for use in the clinic.”
And it appears that PharmaCyte has partnered with the absolute best as Hai Kang’s founder and current chairman, Professor Albert Cheung-Hoi Yu, Ph.D., developed a test that he reported just last month is 10 times more sensitive than the other tests being used to detect the virus.
As a matter of fact, it’s a test that was published in The New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJM200404083501523), after it proved to be more sensitive, reliable and accurate in detecting the SARS-CoV (SARS) virus during the 2002-2003 outbreak in China. Hai Kang’s test for SARS-CoV-2 was developed when Professor Yu and his team re-examined the same technology and methods that were used successfully to develop the test for the SARS virus and found that the test is also applicable to the new coronavirus.
There are two main types of tests being used to detect SARS-CoV-2: molecular and serological. In acute respiratory infections like COVID-19, molecular tests, like the ones used by both the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), are routinely used to detect the presence of viral genetic material in a sample. The specific technique that is used is called Reverse Transcription Polymerase Chain Reaction, or RT-PCR, where genetic material from a patient’s sample is copied and then compared to the genetic sequence of the virus that you’re trying to detect. And specifically related to COVID-19, these tests detect the genetic signature (RNA) of the SARS-CoV-2 virus in swab samples.
However, with every test, there’s a “limit” at which you can still detect a signal. A negative result with the molecular test means that the virus that causes COVID-19 was not found in the sample “above the limit” of detection, but it is still possible to have very low levels of the virus in the body; therefore, these tests will produce a “false negative” because they need a larger sample of genetic material to detect the virus.
Hai Kang says that its testing kit, on the other hand, eliminates the false negatives by improving upon the RT-PCR tests with its own Enhanced Fluorescent Real-Time Reverse Transcription-Polymerase Chain Reaction (ERT-PCR) tests, which are so sensitive that they only require a minimum sample to detect the virus. The company states that the RT-PCR detection technology being used around the world must use 50 to 100 viral genes for testing, while Hai Kang’s ERT-PCR test only needs to use one viral gene to detect the virus.
Professor Yu, who is also the Chairman of the Hong Kong Biotechnology Association, told reporters last month that after comparing his company’s testing kits for SARS-CoV-2 to all other RT-PCR technologies, “Our method is the most sensitive method in the world.”
About PharmaCyte Biotech
PharmaCyte Biotech, Inc. is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment-related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.